Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085208
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/20/1981 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/23/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/17/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/13/1999 SUPPL-21 Labeling

Label is not available on this site.

01/18/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

08/02/1995 SUPPL-19 Labeling

Label is not available on this site.

08/13/1993 SUPPL-18 Labeling

Label is not available on this site.

01/28/1993 SUPPL-17 Labeling

Label is not available on this site.

06/19/1992 SUPPL-16 Labeling

Label is not available on this site.

08/12/1991 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/04/1990 SUPPL-14 Labeling

Label is not available on this site.

11/14/1988 SUPPL-12 Labeling

Label is not available on this site.

05/23/1988 SUPPL-11 Labeling

Label is not available on this site.

06/17/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/21/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/13/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/24/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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